• 通过对89位制药与CRO高管展开调研，报告揭示出三大趋势——差异化创新、全球化深化与务实的AI应用，正定义中国临床试验的新篇章。
2025年11月14日，L.E.K.咨询携手研发客（PharmaDJ）发布联合报告《创新前行，全球共进：中国临床试验发展的新篇章（Advancing Innovation and Global Reach: The Next Chapter in China’s Clinical Trial Development）》。报告指出，中国的临床研发生态系统正进入一个关键阶段，其特点是更具创新性、更深层次的全球融合，以及对包括人工智能在内的智能化工具的积极应用。
报告基于最新分析与行业洞察指出，过去十年间，有利的政策改革与持续的研发投入已深刻重塑中国临床研发格局，为跨国与本土制药企业的下一阶段增长奠定了坚实基础。
报告显示，中国临床试验数量已迅速增长至接近美国水平，并在2024年超过欧洲，达到美国的约80%、高出欧盟约10%，凸显了中国在全球医药研发版图中的重要地位。展望未来，报告认为三大趋势将塑造中国临床研发的下一个阶段：1. 更多差异化、创新型疗法的开发；2. 中国生物医药创新的持续全球化布局；3. AI与智能临床工具的加速应用。
“中国的临床研发不仅规模在扩大，也在变得更具创新性、全球化与数字化。” L.E.K.咨询合伙人、亚洲医疗健康业务负责人陈玮（Helen Chen）表示，“那些能够将差异化科学与跨境战略及务实AI应用相结合的企业，将更有能力加快推进临床进程，降低后期风险，并为患者带来更优治疗成果。”
“许多大型制药企业与中国生物技术公司之间的重大交易都是基于中国数据进行的，”研发客总裁兼出版人戴佳凌说道，“未来，我们认为中国将成为临床开发更为重要的市场，不仅对本土企业如此，对全球制药公司而言也是一样，在中国开展临床不但能让他们更加灵活启动早期临床，后期临床阶段也能充分利用庞大的患者群体加速临床招募。”
报告要点
-
创新：对“全球首创”（first-in-class）与“同类最佳”（best-in-class）创新项目及下一代技术的投资持续增加，推动临床研发从早期向中后期转移，并创造更多差异化空间。
-
全球化：“从中国走向世界”的临床试验与授权合作正在扩大，为跨国企业提供获取差异化资产的新机会，也为具备国际标准能力的合同研究组织（CRO）提供多区域执行支持的契机。
-
AI赋能：AI的短期应用主要集中在数据分析与管理领域，未来随着制药企业和CRO将AI进一步整合进核心研发流程，其运营效率有望显著提升。
扫码或点击“阅读原文”免费下载报告
关于研究
该报告纳入了一项覆盖 89 名受访者的行业调研，受访者主要来自制药企业和合同研究组织（CRO）。调研于 2025 年 8 月至 9 月期间完成，由L.E.K.咨询与研发客（PharmaDJ）联合发起。
关于L.E.K.咨询
L.E.K.咨询是一家全球性的战略咨询公司，致力于帮助业务领导者把握竞争优势，获取持续增长。L.E.K.的深刻洞见帮助客户重塑业务发展轨迹，发掘机遇，并为其赋能，以把握每一个关键时刻。自1983年创立以来，L.E.K.团队遍布全球，跨越美洲、欧洲、中东和亚太地区，与来自各个行业的跨国企业、创业企业以及私募股权投资者展开合作，为其提供战略咨询服务。如欲了解更多信息，请访问 lek.com。
关于研发客（PharmaDJ）
研发客由行业资深记者和编辑于2014年创立，目前已经成为中国医药行业权威的多元化平台，包括全媒体资讯、研究院、行业峰会和传播咨询培训等。
我们的关注领域贯穿整个药物的生命周期，从科学转化、药物早期研究到临床开发、商业化定价，以及市场准入策略、公关传播策略等。
目前研发客全媒体资讯平台覆盖网站、微信公众号、雪球、今日头条、领英等中英文平台的官方号，在中国上海、广州、北京、苏州，以及美国新泽西、加拿大温哥华、日本东京、大阪等地常驻资深编辑和撰稿人，推出多个具有影响力的专栏。我们希望通过研究、调研和报道，成为中国医药行业的灯塔。
New L.E.K.–PharmaDJ Report Reveals China’s Clinical Development Nears U.S. Scale as Innovation and AI Adoption Accelerate
Three trends define China’s next chapter in clinical trials — more differentiated innovation, deeper globalization, and pragmatic AI adoption — based on a survey of 89 pharma and CRO leaders
SHANGHAI & BOSTON — November 14th, 2025 — L.E.K. Consulting, in collaboration with PharmaDJ, today released Advancing Innovation and Global Reach: The Next Chapter in China’s Clinical Trial Development, a new report that outlines how China’s clinical development ecosystem is entering a pivotal phase marked by greater innovation, increasing global integration and the adoption of smarter tools such as AI.
Drawing on fresh analysis and industry input, the report highlights how favorable policy reforms and sustained R&D investment have transformed China’s clinical development landscape over the past decade — laying the groundwork for the next wave of growth for both multinational and Chinese companies.
According to the report, China’s clinical trial volume has surged to nearly U.S. scale and now tops Europe — about 80% of U.S. levels and approximately10% above the EU in 2024. This increase underscores the country’s emergence as a major global player. Looking ahead, three strategic trends are set to shape the market: (1) development of more innovative and differentiated therapies, (2) continued globalization of Chinese biopharma innovation, and (3) increased adoption of AI and smarter clinical trial tools.
“China’s clinical development is not just getting bigger — it’s becoming more innovative, more global and more digital,” said Helen Chen, Partner and Head of Asia Healthcare at L.E.K. Consulting. “Leaders that pair differentiated science with cross-border strategies and pragmatic AI adoption will be best positioned to move faster, de-risk late-stage programs and deliver better outcomes for patients.”
“Many mega transaction deals between Big Pharma and China’s biotech companies are built on China-only data,” said Jialing Dai, PharmaDJ’s President and Publisher. “In the future, we view China as a more important market for clinical development, not only for local players but also for all pharma/biotech companies around the world. By leveraging fixability in early phase and the large population in later phase in China, we can deliver innovative therapies in a faster pace to patients. ”
Report Highlights
-
Innovation: Rising investment in first-/best-in-class assets and next-generation modalities is accelerating the shift from early to late stages and creating more room for clinical differentiation.
-
Globalization: China-to-global trials and licensing are expanding, creating opportunities for multinational companies to access differentiated assets and for CROs (contract research organizations) with global-standard capabilities to support multiregional execution.
-
AI enablement: Near-term adoption is concentrating in data analysis and management, with broader operational gains expected as pharmas and CROs integrate AI into core clinical workflows.
About the Research
The report incorporates an industry survey of 89 respondents — primarily from pharmaceutical companies and CROs — completed in August and September 2025 and was co-sponsored with PharmaDJ.
About L.E.K. Consulting
We're L.E.K. Consulting, a global strategy consultancy working with business leaders to seize competitive advantage and amplify growth. Our insights are catalysts that reshape the trajectory of our clients' business, uncovering opportunities and empowering them to master their moments of truth. Since 1983, our worldwide practice — spanning the Americas, Europe, Middle East and Asia-Pacific — has guided leaders across all industries, from global corporations to emerging entrepreneurial businesses and private equity investors. Looking for more? Visit www.lek.com.
About Pharma DJ
Cofounded by experienced journalists and editors in 2014, PharmaDJ is the leading business intelligence and media portal for Pharmaceutical and Biotech industry in China. Since then, it has built a wide platform to serve the industry need. Now, it provides different services including business intelligence, business strategy consulting and conference/training program to its readers and clients.
With the editorial team located in Shanghai, Guangzhou, Beijing, Suzhou, New Jersey and Hawii, our focus covers the entire drug life cycle, from early drug research, translational science, clinical development, commercial, market access and PR communication strategies.